Trial Outcomes & Findings for Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice (NCT NCT01768858)

NCT ID: NCT01768858

Last Updated: 2019-01-28

Results Overview

The BMQ-Specific Scale comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication (Specific-Concerns). Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 (lowest score) to 50 (highest score). Higher scores indicate stronger beliefs.

• Recruitment status: COMPLETED
• Target enrollment: 96 participants
• Primary outcome timeframe: Baseline and 12 months
• Results posted on: 2019-01-28

Participant Flow

All enrolled participants

Participant milestones

Measure	Participants Receiving Adalimumab Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Overall Study STARTED	96
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Measure	Participants Receiving Adalimumab Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Overall Study Lost to Follow-up	9
Overall Study Lack of Efficacy	8
Overall Study Serious Adverse Event	1
Overall Study Participant moved to Germany	1
Overall Study Aggravation of NY Heart Assoc 3 status	1
Overall Study Exanthema	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice

Baseline characteristics by cohort

Measure	Participants Receiving Adalimumab n=96 Participants Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Age, Continuous	47.99 years STANDARD_DEVIATION 14.60 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Number of participants per disease subgroup Rheumatoid arthritis (RA)	42 Participants n=5 Participants
Number of participants per disease subgroup Ankylosing spondylitis (AS)	29 Participants n=5 Participants
Number of participants per disease subgroup Plaque psoriasis (PS)	13 Participants n=5 Participants
Number of participants per disease subgroup Psoriatic arthritis (PsA)	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: Participants with available data

The BMQ-Specific Scale comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication (Specific-Concerns). Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 (lowest score) to 50 (highest score). Higher scores indicate stronger beliefs.

Outcome measures

Measure	Participants Receiving Adalimumab n=72 Participants Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months	-1.4 units on a scale Standard Deviation 5.0

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: Participants with available data

The BMQ-Specific Scale comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication (Specific-Concerns). Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 (lowest score) to 50 (highest score). Higher scores indicate stronger beliefs. The MMAS is a 4-item self-reported measure of medication-taking behavior. It measures intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse). The MMAS consists of 4 questions which can be answered with yes (0) and no (1). The MMAS score is the sum of all four questions and ranges from 0 (non-adherent) to 4 (adherent).

Outcome measures

Measure	Participants Receiving Adalimumab n=73 Participants Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Correlation Between Beliefs About Medicines Questionnaire (BMQ) Specific Score and Adherence to Treatment as Measured by the Morisky Medication Adherence Scale (MMAS) at 12 Months	-.173 Spearman correlation coefficient

SECONDARY outcome

Timeframe: At Month 3 and Month 12

Population: Participants with available data

The MMAS is a 4-item self-reported measure of medication-taking behavior. It measures intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse). The MMAS consists of 4 questions which can be answered with yes (0) and no (1). The MMAS score is the sum of all four questions and ranges from 0 (non-adherent) to 4 (adherent).

Outcome measures

Measure	Participants Receiving Adalimumab n=77 Participants Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Change in Morisky Medication Adherence Scale (MMAS) Scores From Month 3 to Month 12	0.2 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: At Month 3 and Month 12

Population: Participants with available data

The 11-item Treatment Satisfaction Questionnaire for Medication (TSQM) Version II is an instrument to assess participants' satisfaction with medication, providing scores on four scales (side effects, effectiveness, convenience, and global satisfaction). The 11 questions can be answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores range from 0 to 100 and higher scores represent higher satisfaction.

Outcome measures

Measure	Participants Receiving Adalimumab n=77 Participants Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12 Efficacy	6.80 units on a scale Standard Deviation 23.52
Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12 Side Effects	1.95 units on a scale Standard Deviation 17.72
Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12 Convenience	3.46 units on a scale Standard Deviation 16.50
Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12 Global Satisfaction	3.28 units on a scale Standard Deviation 24.45

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9, Month 12

Population: Participants with rheumatoid arthritis with available data

The RADAI is a questionnaire for participants used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness, and (6) tender joints rated on a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.

Outcome measures

Measure	Participants Receiving Adalimumab n=53 Participants Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time Month 6	2.75 units on a scale Standard Deviation 1.58
Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time Month 3	3.99 units on a scale Standard Deviation 1.64
Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time Month 9	1.83 units on a scale Standard Deviation 1.64
Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time Month 12	1.86 units on a scale Standard Deviation 1.79
Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time Baseline	5.52 units on a scale Standard Deviation 1.66

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9, Month 12

Population: Participants with ankylosing spondylitis with available data

The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.

Outcome measures

Measure	Participants Receiving Adalimumab n=28 Participants Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time Baseline	5.39 units on a scale Standard Deviation 1.52
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time Month 3	3.61 units on a scale Standard Deviation 2.05
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time Month 6	2.98 units on a scale Standard Deviation 1.96
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time Month 9	1.72 units on a scale Standard Deviation 1.44
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time Month 12	2.34 units on a scale Standard Deviation 2.30

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9, Month 12

Population: Participants with available data

C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy individuals is usually lower than 1 mg/dL, slightly increasing with age, and increased in a variety of disorders such as rheumatic diseases.

Outcome measures

Measure	Participants Receiving Adalimumab n=90 Participants Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Change in C-reactive Protein (CRP) Concentration Over Time Baseline	1.60 mg/dL Standard Deviation 2.75
Change in C-reactive Protein (CRP) Concentration Over Time Month 3	0.87 mg/dL Standard Deviation 1.66
Change in C-reactive Protein (CRP) Concentration Over Time Month 6	1.54 mg/dL Standard Deviation 8.68
Change in C-reactive Protein (CRP) Concentration Over Time Month 9	0.47 mg/dL Standard Deviation 0.74
Change in C-reactive Protein (CRP) Concentration Over Time Month 12	0.65 mg/dL Standard Deviation 1.25

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9, Month 12

Population: Participants with available data

Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body, and is based on the sedimentation and aggregation of erythrocytes (red blood cells). A higher ESR is indicative of increased inflammation. The normal range in healthy individuals is 0 - 10 mm/h for men and 0-15 mm/h for women.

Outcome measures

Measure	Participants Receiving Adalimumab n=86 Participants Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Changes in Erythrocyte Sedimentation Rate (ESR) Over Time Baseline	29.3 mm/hr Standard Deviation 23.7
Changes in Erythrocyte Sedimentation Rate (ESR) Over Time Month 3	24.1 mm/hr Standard Deviation 20.5
Changes in Erythrocyte Sedimentation Rate (ESR) Over Time Month 6	17.4 mm/hr Standard Deviation 15.8
Changes in Erythrocyte Sedimentation Rate (ESR) Over Time Month 9	17.8 mm/hr Standard Deviation 18.9
Changes in Erythrocyte Sedimentation Rate (ESR) Over Time Month 12	16.0 mm/hr Standard Deviation 16.7

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9, Month 12

Population: Participants with psoriasis with available data

The Psoriasis Area and Severity Index (PASI) is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

Outcome measures

Measure	Participants Receiving Adalimumab n=12 Participants Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Change in Psoriasis Area and Severity Index (PASI) Score Over Time Baseline	18.0 units on a scale Standard Deviation 11.5
Change in Psoriasis Area and Severity Index (PASI) Score Over Time Month 3	5.1 units on a scale Standard Deviation 6.6
Change in Psoriasis Area and Severity Index (PASI) Score Over Time Month 6	1.5 units on a scale Standard Deviation 1.9
Change in Psoriasis Area and Severity Index (PASI) Score Over Time Month 9	1.8 units on a scale Standard Deviation 2.5
Change in Psoriasis Area and Severity Index (PASI) Score Over Time Month 12	5.9 units on a scale Standard Deviation 6.8

Adverse Events

Participants Receiving Adalimumab

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants Receiving Adalimumab n=96 participants at risk Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
Nervous system disorders Headache	1.0% 1/96 • Treatment emergent serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 62 weeks. TESAEs were collected whether elicited or spontaneously reported by the participant. Nonserious adverse events were not collected for this study.

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER